Status:
WITHDRAWN
AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation
Lead Sponsor:
Acutus Medical
Conditions:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study.
Detailed Description
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and efficacy of the AcQBlate Force Sensing System in the ablation...
Eligibility Criteria
Inclusion
- Male or female between the ages of 18 to 80 years at time of consent
- Clinically indicated and scheduled for a de novo catheter ablation of symptomatic PAF or PerAF.
- Refractory to Antiarrhythmic Drug (AAD) treatment
- Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.
Exclusion
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis.
- Continuous episodes of AF Duration:
- PAF: AF duration lasting longer than 7 days
- Persistent AF: AF duration lasting longer than 12-months.
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- An implantable cardiac defibrillator (ICD) or pacemaker.
- Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
- Structural heart disease or cardiac history as described below:
- Left ventricular ejection fraction (LVEF) \< 40% based on transthoracic echocardiogram (TTE) within the previous 180-days.
- Left atrial size \> 55 mm based on transthoracic echocardiogram (TTE) measurement of the anteroposterior diameter, parasternal long-axis view in M Mode and performed within the previous 180-days.
- Evidence of heart failure (NYHA Class III or IV)
- Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
- Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
- Coronary artery bypass graft (CABG) within the last 180-days or coronary angioplasty (PTCA) procedure within the last 90-days.
- Unstable angina or ongoing myocardial ischemia.
- Myocardial infarction within the previous 180-days (sub-endocardial infarct within previous 90-days).
- Severe uncontrolled systemic hypertension (systolic pressure \> 240 mm Hg, diastolic pressure \> 140 mm Hg) recorded within the last 30 days.
- Moderate or severe valvular heart disease (stenosis or regurgitation).
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
- Presence of a left atrial appendage occlusion device.
- Previous PV stenting or evidence of PV stenosis.
- Presence of Left Atrial Thrombus
- Body Mass Index (BMI) \> 42 kg/m2
- Estimated Glomerular Filtration Rate (eGFR) of \<40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
- History of blood clotting or bleeding disease.
- ANY prior history of documented cerebral infarct, or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
- History of chronic obstructive pulmonary disease (COPD) requiring oral or IV steroid use in the previous 12-months.
- History of obstructive sleep apnea not currently being treated.
- Pregnant or lactating (current or anticipated during study follow-up).
- Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study.
- Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04904354
Start Date
November 1 2023
End Date
December 1 2025
Last Update
November 13 2023
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